FDA 510(k) clearance for DiLumen C2

Speed readFDA: We have received United States Food and Drug Administration (FDA) 510(k) clearance for the DiLumen C2, our second-generation endoscopic accessory.SAGES: Gastroenterologists show great interest in our DiLumen C2 product.

A year later, we released a new video with our chairman, Dr. Peter Johann. In it, Peter mentions our product pipeline. Not only have we expanded and further refined our product pipeline, our marketing and sales activities are continuing at a rapid pace.

SAGES 2018 in Seattle

The SAGES 2018 Annual Meeting was held April 11-14, 2018 in Seattle, WA. With more than 2,300 members, this Society is the premier organisation for minimally invasive endolumenal procedures in the field of general surgery. In 2018, for the first time ever, Lumendi displayed the DiLumen C2.

Products on display for visitors at the annual meeting.

Eric Coolidge, Vice President Marketing told us:

This was an excellent opportunity to gain some high-level feedback from important surgical thought leaders.

The exhibit hall opened the afternoon of Wednesday, April 11 and ran all day Thursday and Friday. Eric told us that he was also pleased to see the Lumendi booth got significantly more traffic than last year in Houston.

The team was busy pre-qualifying leads and the result was very satisfying. These come mostly from the US, though several are from far away places.

SAGES is the number one meeting of preeminent leaders in gastrointestinal endolumenal surgery. Attending gave Lumendi staff the opportunity to meet plenty of interesting experts.

The feedback we collected for DiLumen and DiLumen C2 was very positive, one reason being that many surgeons are eager to begin using our tools. Many others described their positive experiences while using DiLumen in their work so far.

Visitors interested in how DiLumen works.

FDA 510(k) clearance for DiLumen C2

Today, Lumendi has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the DiLumen C2. This is our second-generation endoscopic accessory, that helps experts accomplish two things:

Today, endoscopic removal of relatively simple polyps can be done during a medical check-up. In colonoscopy, such work has become a well established standard (e.g., polypectomy). Nevertheless, more complex procedures challenge medical experts’ skills.

One reason for issues can be that the larger type of polyp is already part of the intestinal wall. Moreover, human intestines are very flexible. In turn, they represent an unstable environment for grasping and removing any kind of human tissue.

The result is that using ESD (Endoscopic Mucosal Resection) to remove complex polyps is very difficult and cannot always be done to the preferred standard for the patient’s sake.

For the well trained expert that handles such complex and demanding techniques as ESD, Lumendi’s DiLumen Ig™ endolumenal interventional grasper can make a real difference. It effectively supports the expert’s skillful undertaking of a minimally invasive therapy in two ways, namely:

making the area where the procedure occurs a stable zone, AND

drastically improving visibility for the medical expert.

Hence, complex polyps can more easily be removed using endoscopy.

By the way, we are also waiting on clearance for our scissors. These will make DiLumen C2 even better by allowing the cutting of polyps to occur more quickly and safely. We will update you on these regulatory developments within the next 12 weeks.

What is your opinion?

Over 300 procedures have been completed with the commercially available DiLumen EIP. No serious adverse events were recorded. Three clinical studies have also been completed, further demonstrating safety and cost effectiveness.

However, we are also interested in YOUR opinion. What do you think?

As a Lumendi investor, how do you perceive the way forward?

As an endoscopist or surgeon, would you like to test-drive our products for conducting minimally invasive endoscopic therapy? If the answer is yes, please let us know below.